AbbVie Elated as Pharmacyclics's Imbruvica Shines in Combo Trial
March 17, 2015
By Krystle Vermes, BioSpace.com Breaking News Staff
California-based Pharmacyclics, Inc. , which was recently acquired by AbbVie , announced on March 16 that an Independent Data Monitoring Committee had examined HELIOS. The international Phase III double-blind trial evaluated ibrutinib in combination with bendamustine and rituximab versus a placebo.
After assessing the study, the committee unanimously agreed that it should be unblinded based on clinically meaningful and statistically significant improvement in progression-free survival.
Ibrutinib, marketed as IMBRUVICA, is an oral once-daily therapy that inhibits a protein called Bruton’s tyrosine kinase. BTK is the signaling molecule in the B-cell receptor, which plays a role in the spread of malignant B cells within the body. Ibrutinib blocks the signals that encourage the multiplication of malignant cells.
"We are delighted by the superior efficacy observed in CLL and SLL patients treated with IMBRUVICA in combination with BR compared to patients in the placebo-controlled BR arm and look forward to sharing these results with the scientific community and U.S. regulators," said Danelle James, head of oncology at Pharmacyclics. "These results build upon early results in the Phase I/II program and are very encouraging as we continue to explore the benefits IMBRUVICA provides to patients when it is combined with other treatments."
Finding Additional Use for IMBRUVICA
In January 2015, the U.S. Food and Drug Administration announced that IMBRUVICA had been approved for patients with Waldenström’s macroglobulinemia, a form of cancer that begins in the immune system.
“Today’s approval highlights the importance of development of drugs for supplemental indications,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, at the time of the announcement. “Continued research has discovered new uses of IMBRUVICA.”
Waldenström’s macroglobulinemia is a type of non-Hodgkin lymphoma. The disease causes abnormal blood cells, known as B-cells. They grow within the bone marrow, lymph nodes, liver, and spleen. In 2014, more than 70,000 people in the U.S. were diagnosed with non-Hodgkin lymphomas.
The FDA granted breakthrough therapy designation, priority review, and orphan product designation to IMBRUVICA for the treatment of the disease. Clinical evidence had shown that the drug could over significant improvement over other therapies on the market.
Approval from the FDA was based on a clinical study of 63 previously treated patients. All participants had received a daily 420-milligram orally administered dose of IMBRUVICA until the side effects became intolerable or the disease progressed. About 62 percent of participants saw their cancer shrink after treatment.
BioSpace Temperature Poll
After Amgen Inc. said last week that it will close its South San Francisco facility acquired during its $10 billion buyout of Onyx Pharmaceuticals and will lay off 300 of Oynx’s 750 workers, BioSpace is wondering—will the number of mergers and acquisitions completed in 2014 mean a “streamlining” of biotech jobs in the Bay Area? Tell us your thoughts.